1. Field of the Invention
The invention is directed to a closing system for a natural or an artificial intestinal outlet, the system including an inflatable balloon having an approximately toroidal structure.
2. Description of the Prior Art
The medical management of intestinal stomata continues to be an ongoing, daily problem. One very common method is to collect stool in receptacles that are used in the form of adhesive bags. This extracorporeal storage is associated with the problem of odor nuisance, and above all the risk of loosening of the bag from the skin and soiling.
In addition to extracorporeal collection systems, seals were developed with the objective to create an indwelling seal of the stoma, allowing intermittent emptying of the stool when removing the sealing structure from the body. Fundamental problems of such closure systems proved to be the traumatic effect of the sealing device on the exposed anatomical structures during prolonged placement, as well as the insufficient anchoring of the sealing system inside the body, and tendency to slip out of the stoma when, e.g., the intra-abdominal pressure abruptly increases.
For the treatment of fecal incontinence, similar approaches have been taken. In the care of immobilized patients, bag like collecting systems are established, which are affixed to the peri-anal skin. The bag usually has a tube element connected to it, draining the stool from the bag-like collector to a remote collecting unit. Problematic remain the effect of the bag fixation on the body skin and the degradation of the peri-anal skin, due to its permanent exposure to the stool. Not to mention the tendency of the affixed bag to loosen and to soil the care area.
Alternatively to peri-anally affixed bags, stool draining catheters, so called rectal tubes, can be used. A large bore catheter element is inserted through the anus into the rectum, taking up the feces there and draining them into a connected receptacle. Because of their limited flexibility, rectal tubes can have severe traumatic effects on the exposed colo-rectal and anal structures, reaching from ulceration of the surface to penetration of the organ wall.
Mobile patients, suffering from fecal incontinence, are, in few cases, using closure plug like devices, introduced trans-anally into the rectum, enabling a certain retention and seal effect. These so called rectal plugs are known for a tendency to slip out of the rectum, as well as painful ano-rectal irritations, when being removed by the patient.
The disadvantages of the described prior art give rise to the problem initiating the invention, that of creating a closing system for a natural or artificial intestinal outlet, that is of uncomplicated construction and manufactured from inexpensive materials, can readily be inserted into the body, has sufficient anchoring properties, follows organ and body movements, and causes the smallest possible pressure load on the exposed tissues, enabling indwelling placement with the least possible tissue irritation and risk of tissue perfusion impairment. Further, the invented device introduces a technique of allowing for a seal against solid and semisolid bowel contents, but at the same time granting the continuous release of bowel gas from the intestine to the outside of the body, thereby preventing the progressive flatulence of the abdomen. Beyond, the invented device further grants an access channel for the infusion of an irrigation fluid, enabling the patient to install the fluid and move freely, until the peristaltic bowel activity sets in and the seal is being removed.